The present invention relates to radio-frequency ablation of tumors and the like and, in particular, to a device allowing for the simultaneous use of multiple ablation electrodes.
Ablation of tumors, such as liver (hepatic) tumors, uses heat or cold to kill tumor cells. In cryosurgical ablation, a probe is inserted during an open laparotomy and the tumor is frozen. In radio-frequency ablation (RFA), an electrode is inserted into the tumor and current passing from the electrode into the patient (to an electrical return typically being a large area plate on the patient's skin) destroys the tumor cells through resistive heating.
A simple RFA electrode is a conductive needle having an uninsulated tip placed within the tumor. The needle is energized with respect to a large area contact plate on the patient's skin by an oscillating electrical signal of approximately 460 kHz. Current flowing radially from the tip of the needle produces a spherical or ellipsoidal zone of heating (depending on the length of the exposed needle tip) and ultimately a lesion within a portion of the zone having sufficient temperature to kill the tumor cells. The size of the lesion is limited by fall-off in current density away from the electrode (causing reduced resistive heating), loss of heat to the surrounding tissue, and limits on the amount of energy transferred to the tissue from the electrode. The electrode energy is limited to avoid charring, boiling and vaporization of the tissue next to the electrode, a condition that greatly increases the resistance between the electrode and the remainder of the tumor. The tissue next to the electrode chars first because of the high current densities close to the electrode and thus creates a bottleneck in energy transfer.
Several approaches have been developed to increase energy delivered to tissue without causing charring. A first method places temperature sensors in the tip of the electrode to allow more accurate monitoring of temperatures near the electrode and thereby to allow a closer approach to those energies just short of charring. A second method actively cools the tip of the electrode with circulated coolant fluids within the electrode itself. A third method increases the area of the electrode using an umbrella-style electrode in which three or more electrode wires extend radially from the tip of the electrode shaft after it has been positioned in the tumor. The greater surface area of the electrode reduces maximum current densities. A fourth method injects a liquid (usually saline) into the tissue to increase conductivity. The effect of all of these methods is to increase the amount of energy deposited into the tumor and thus to increase the lesion size allowing more reliable ablation of more extensive tumors.
A major advantage of RFA in comparison to cryosurgical ablation is that it may be delivered percutaneously, without an incision, and thus with less trauma to the patient. In some cases, RFA is the only treatment the patient can withstand. Further, RFA can be completed while the patient is undergoing a CAT scan.
Nevertheless, despite the improvements described above, RFA often fails to kill all of the tumor cells and, as a result, tumor recurrence rates of as high as 50% have been reported.
The parent application to the present application describes a system of increasing the effective lesion size through the use of a bipolar operating mode where current flows between two locally placed umbrella electrodes rather than between an individual electrode and a large area contact plate. The bipolar current flow “focuses” the energy on the tumor volume between the two umbrella electrodes producing a lesion greater in volume with higher heating and more current density between electrodes than would be obtained by a comparable number of monopolar umbrella electrodes operating individually. In this respect, the bipolar operation allows treatment of larger tumors and more effective treatment of targeted tumors due to greater tissue heating with a single placement of electrodes, improving the speed and effectiveness of the procedure and making it easier to determine the treated volume over procedures where an individual electrode is moved multiple times.
The bipolar technique has some disadvantages. First, it is sensitive to the relative orientation of the two probes. Portions of the probes that are closer to each other will get hotter. Another disadvantage is that for two probe, bipolar systems, all the current exiting the first probe must enter the second probe depositing equal energy near both probes. This can be a problem when one probe is at a location, for example, near a cooling blood vessel, that requires additional deposition energy or independent control of that probe. Generally, too, a single set of bipolar probes can't treat multiple separated tumors.
One alternative is the simultaneous use of multiple probes in monopolar configuration. Here, as with the bipolar technique, the probes may be inserted at one time improving the speed of the procedure and eliminating ambiguity in the treatment volume that may come from repositioning probes. Current flows from each probe to the contact plate on the surface of the patient's skin.
A drawback to this multiple monopolar mode is that the monopolar probes may electrically shield each other causing insufficient heating between the probes. To the extent that the probes are operated at different voltages to accommodate local cooling of one probe, complex current flows can be created both between probes, and between probes and the contact plate making prediction of the ultimate effect of the probes difficult.